DAILY

Providers of high-risk AI systems must draw up technical documentation before placing the system on the market, containing at least the elements of Annex IV, and keep it up to date (Art. 11). SMEs may use a simplified form. This checklist walks through the nine sections of Annex IV.

Applicability

1. Are you the provider of the system, i.e. do you develop it or have it developed and place it on the market under your name?
Art. 3 Nr. 3 KI-VO Open in the law texts
2. Is the system a high-risk AI system under Art. 6?
Art. 6 KI-VO Open in the law texts

Contents under Annex IV

3. General description: intended purpose, provider, version, interaction with hardware and software, forms in which it is placed on the market, user interface and instructions for use?
Anhang IV Nr. 1 KI-VO Open in the law texts
4. Detailed description of elements and development: methods, design choices, system architecture, data requirements and datasheets, human oversight measures, predetermined changes, validation and testing with metrics and logs?
Anhang IV Nr. 2 KI-VO Open in the law texts
5. Monitoring, functioning and control: capabilities and limitations, accuracy for specific groups of persons, foreseeable unintended outcomes and risks, oversight measures, input data specifications?
Anhang IV Nr. 3 KI-VO Open in the law texts
6. Justification why the chosen performance metrics are appropriate for this system?
Anhang IV Nr. 4 KI-VO Open in the law texts
7. Detailed description of the risk management system under Art. 9?
Anhang IV Nr. 5, Art. 9 KI-VO Open in the law texts
8. Description of relevant changes made to the system through its life cycle?
Anhang IV Nr. 6 KI-VO Open in the law texts
9. List of harmonised standards applied or, where none were applied, a description of the solutions adopted and any common specifications applied?
Anhang IV Nr. 7 KI-VO Open in the law texts
10. Copy of the EU declaration of conformity under Art. 47?
Anhang IV Nr. 8, Art. 47 KI-VO Open in the law texts
11. Description of the post-market monitoring system, including the plan under Art. 72?
Anhang IV Nr. 9, Art. 72 KI-VO Open in the law texts

Maintenance and retention

12. Is the documentation drawn up before placing on the market and kept up to date afterwards?
Art. 11 Abs. 1 KI-VO Open in the law texts
13. Is the documentation kept available for the authorities for ten years after placing on the market?
Art. 18 Abs. 1 KI-VO Open in the law texts
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